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Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 40002-2021: Oral hard tissue safety evaluation of toothpastes Status: Valid
Basic dataStandard ID: GB/T 40002-2021 (GB/T40002-2021)Description (Translated English): Oral hard tissue safety evaluation of toothpastes Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: Y43 Word Count Estimation: 10,147 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 40002-2021: Oral hard tissue safety evaluation of toothpastes---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.Oral hard tissue safety evaluation of toothpastes ICS 71.100.40 CCSY43 National Standards of People's Republic of China Safety Evaluation of Toothpaste on Oral Hard Tissue Released on 2021-04-30 2021-11-01 implementation State Administration of Market Supervision and Administration Issued by the National Standardization Management Committee ForewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents. This document was proposed by the China National Light Industry Council. This document is under the jurisdiction of the National Oral Care Products Standardization Technical Committee (SAC/TC492). Drafting organizations of this document. Heilongjiang Research Institute of Light Industry Science, Guangzhou Procter & Gamble Co., Ltd., Holly Chemical (Zhongshan) Co., Ltd., Guangzhou Wei Meizi Industrial Co., Ltd., Jiangsu Snow Leopard Daily Chemical Co., Ltd., Fujian Aijieli Daily Chemical Co., Ltd., Colgate Palmolive (China) Co., Ltd., four West China Stomatological Hospital of Sichuan University, School of Stomatology, Air Force Military Medical University, China Oral Cleaning and Nursing Products Industry Association. The main drafters of this document. Sun Dongfang, Dai Yali, Xiao Mei, Song Shuo, He Qiying, Zheng Wei, Chen Wanjin, Chen Minshan, Xu Zhiliang, Xie Liuqing, Hu Deyu and Zhao Xinyi.IntroductionThe toothpaste produced and sold in our country all refer to the requirements of GB/T 8372.The current requirement for the pH value of toothpaste products is For toothpastes with a pH value of 5.5~10, and the pH value is lower than 5.5, the product responsible party shall provide a test report for the safety evaluation of oral hard tissues according to standard methods. Report. Establishing a scientific and effective hard-tissue safety evaluation method is particularly important for regulating the safety evaluation of low-pH products. The wear value test method adopted in ISO 11609.2017 includes the RDA/REA method and surface wheel corresponding to the radioisotope test. Two test methods of RDA-PE/REA-PE corresponding to the profiler. Among them, the RDA/REA law has been practiced for fifty to sixty years since it was proposed. Historically, the method is mature and reliable as a standard method recognized by the international dental industry. The recycling method specified in this document is an improvement on the traditional demineralization and remineralization test method recognized by the international industry. The microhardness tester measures the changes in the surface hardness of oral hard tissues treated by oral care products, thereby evaluating the effects of oral care products on oral hard tissues. Whether it is safe or not, this method has been unanimously recognized by experts at the internationally renowned academic conference (2016IADR). Safety Evaluation of Toothpaste on Oral Hard Tissue1 ScopeThis document describes the safety evaluation method of toothpaste on oral hard tissues. This document is applicable to the safety evaluation of toothpaste on oral hard tissues using the surface contour method and the circulation method.2 Normative referencesThe contents of the following documents constitute the indispensable clauses of this document through normative references in the text. Among them, dated quotations Only the version corresponding to that date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to This document. GB/T 3358.1 Statistics Vocabulary and Symbols Part 1.General Statistical Terms and Terms Used in Probability GB/T 4340.2 Vickers Hardness Test of Metallic Materials Part 2.Inspection and Calibration of Hardness Tester GB/T 6682 Analytical laboratory water specifications and test methods GB/T 35919 Classification and terminology of oral cleaning and care products QB/T 4780 Determination of Vickers Hardness on Glazed Surface of Ceramics for Daily Use ISO 11609.2017 Dentistry toothpaste requirements, test methods and marking (Dentistry-Dentifrices-Requirements, testmethodsandmarking)3 Terms and definitionsThe terms and definitions defined in GB/T 3358.1 and GB/T 35919 apply to this document.4 Surface profile methodIn accordance with the requirements of ISO 11609.2017 Appendix B.5 Round Robin5.1 General This method is based on the use of a microhardness meter to measure the changes in the surface hardness of the oral hard tissues treated by oral care products, thereby evaluating the oral hardness. Whether the cavity care products are safe for the oral hard tissues. This method selects very strict test conditions. In special circumstances, more complicated test methods that are closer to clinical conditions can also be used. 5.2 Device 5.2.1 Micro hardness tester The requirements of the microhardness tester are implemented in accordance with GB/T 4340.2, and the test load range in this method should meet 0.05kg~ 0.5kg. 5.2.2 Grinding and polishing equipment Silicon carbide grinding discs with continuous particle size changes (the finest can reach P1200), which can use diamond slurry for sample polishing and/or etc. Effective automatic grinding and polishing device. Note. Other enamel and dentin polishing methods that meet the baseline requirements of the specimen can also be used, such as the diamond powder method. 5.2.3 Electric heating constant temperature drying oven The temperature can be controlled to be constant at 37℃±2℃. 5.3 Preparation of enamel and dentin specimens Use caries-free, erupted or non-erupted human permanent teeth, or bovine teeth. The size of these teeth needs to meet the following test requirements. Make Use suitable utensils (such as curettes, scalpels, etc.) to remove all soft tissue residues, sterilize and store teeth with 0.1% thymol. Note 1.1000mL 0.1% (mass fraction) thymol preparation method. Weigh 1g of thymol, dissolve in 1mL of absolute ethanol, and then add water to make the volume up to 1000mL. Note 2.If it is known that the physical and chemical properties of tooth enamel and dentin will not be changed, other antibacterial and storage solutions can also be used. Use a dental drill or a cutting disc to cut the enamel-dentin junction into two parts. Use the crown part to prepare the tooth enamel specimen, and use the tooth root part To prepare dentin specimens, the size of the specimen should not be less than 3mm×3mm×3mm. Note 3.According to the size and shape of the crown and root, a tooth can prepare up to two specimens. Put the enamel and dentin blocks upside down in the mold for embedding, and the outer surface of the specimen needs to be facing down. Embed the specimen in In epoxy resin, make sure that the specimen is placed flat and parallel to the resin surface. The dentin and enamel specimens that have been embedded, using a series of particle sizes Silicon carbide sandpaper grinding and polishing paste and diamond grinding and polishing paste polished until the tooth surface is smooth and uniform, without visible cracks and blemishes. The use of grinding and polishing reagents does not It can affect the physical and chemical properties of the tooth surface. Note 4.It is recommended to use P320, P600, P800, 9μm, 3μm and 1μm grinding and polishing conditions in sequence. The Vickers hardness was measured by a microhardness tester, and the specimens were screened by the hardness value. The measurement conditions are. load 300g, last 15s. Each sample is measured at four points, and the measurement position needs to be shown in Figure 1.The distance between the measuring point and the edge of the tooth block should not be less than 0.5mm. Also need to be evenly distributed For the four measuring points, the distance a and b between each measuring point shall not be less than 1mm. The hardness of the sample is the average of the measured values at four points. The initial Vickers surface hardness of bovine dentin specimens that can be included in the test ranges from 30HV to 50HV, and the initial Vickers surface hardness of human dentin specimens The degree range is 30HV~70HV. The Vickers surface hardness of enamel specimens of bovine and human teeth ranges from 250HV to 350HV. whether Tooth enamel or dentin, both need to be randomly grouped according to the surface hardness value, each group has 8 tooth blocks. Figure 1 Location of Vickers hardness measurement The specimens should be kept in deionized water until they are used. Deionized water at least meets the requirements of Grade III water in GB/T 6682 Claim. 5.4 Preparation of control samples 5.4.1 Positive control Use deionized water as a positive control for the test. 5.4.2 Negative control Prepare 1% citric acid as the negative control of the experiment. 5.5 Preparation of test samples 5.5.1 Preparation of toothpaste slurry Toothpaste and deionized water are weighed according to the mass ratio of 1.3, stirred and mixed to avoid foam. Each specimen needs At least 5mL toothpaste slurry. 5.5.2 Preparation of mouthwash sample Use mouthwash samples directly to process the specimens, and each specimen needs at least 5mL mouthwash. 5.6 Preparation of saliva Human saliva or artificial saliva can be used. If artificial saliva is used, its preparation and requirements are as follows. a) Preparation of 1L artificial saliva. accurately weigh 0.246g (accurate to ±0.0005g) calcium nitrate (or 0.354g tetrahydrate Calcium acid), 0.1225g (accurate to ±0.0005g) potassium dihydrogen phosphate, 9.685g (accurate to ±0.0005g) potassium chloride and 4.184g (accurate to ±0.0005g) bis(2-hydroxyethyl)aminotris(hydroxymethyl)methane in a 1L beaker, add 800mL Deionized water. Stir well to dissolve. Adjust the pH value to 7.0±0.05 with 1mol/L HCl. Transfer this solution to 1L In the volumetric flask, make the volume up to the mark with deionized water; b) The final concentration of each component in artificial saliva is. 1.5mmol/L calcium nitrate, 0.9mmol/L potassium dihydrogen phosphate, 130mmol/L Potassium chloride, 20mmol/L bis(2-hydroxyethyl)aminotris(hydroxymethyl)methane. 5.7 Test cycle Soak the specimen in toothpaste slurry or mouthwash for 5 minutes, control the temperature at 37°C±2°C, then wash the specimen thoroughly with deionized water, and then use it Soak the specimen with human saliva or artificial saliva for 55 minutes, and the temperature is controlled at 37℃±2℃. Repeat the above operation for a total of 6 cycles. Finally use The human saliva or artificial saliva immersed the specimen for no less than 12h, and the temperature was controlled at 37℃±2℃. 5.8 Detection After the cycle treatment, the tooth block sample was rinsed with deionized water and stored in deionized water for later hardness testing. A Vickers hardness tester was used to measure the surface microhardness of the cyclically processed tooth block samples. For the distribution of measuring points, see (Figure 1) Vickers Hardness measurement location map. Before measuring, make sure that the surface of the sample is dry. The measuring condition of the hardness tester is 0.3kg load, lasting 15s, and the measuring operation Work in accordance with QB/T 4780. 5.9 Data processing The hardness value change ΔHV before and after the cycle treatment of each tooth is calculated in formula (1). ΔHV=HVpost-HVpre (1) Where. ΔHV ---The change in hardness value of each tooth piece, in kilograms per square millimeter (kg/mm2); HVpost---The hardness value measured after cyclic processing, in kilograms per square millimeter (kg/mm2); HVpre --- The hardness value measured before the cycle treatment, in kilograms per square millimeter (kg/mm2). Note. All subsequent statistical analyses are based on ΔHV. 5.10 Statistical analysis methods According to the definition of validity test and non-inferiority test in GB/T 3358.1, the analysis of ΔHV is as follows. a) Validity test. A bilateral test is carried out at the 95% confidence level, and the average value of the positive control group is significantly better than the average value of the negative control group. b) Non-inferiority test. A one-sided test is performed at the 95% confidence level, and the difference between the test product group and the positive control group is statistically significant Significance is less than the minimum effective difference, where the minimum effective difference is equal to half of the average difference between the positive control group and the negative control group. change In other words, a one-sided test is performed at the 95% confidence level, and the average value of the test product group is significantly better than that of the positive control group and the negative control group. average value. c) The above two requirements should be met at the same time, and the tested product can be judged as non-inferior to the positive control. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 40002-2021_English be delivered?Answer: Upon your order, we will start to translate GB/T 40002-2021_English as soon as possible, and keep you informed of the progress. 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